FDA.reportPublic FDA data

Application 076532

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMVASTATINSIMVASTATINTABLET; ORAL5MGNoNo
002SIMVASTATINSIMVASTATINTABLET; ORAL10MGNoNo
003SIMVASTATINSIMVASTATINTABLET; ORAL20MGNoNo
004SIMVASTATINSIMVASTATINTABLET; ORAL40MGNoNo
005SIMVASTATINSIMVASTATINTABLET; ORAL80MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.3e48217f-8175-4e9b-9fd0-909be4bbba952026-01-13Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
simvastatinSIMVASTATINNorthwind Health Company, LLCdb0f4c5a-e8e4-3ab1-e053-2995a90a1f9a2026-01-01Warnings, Adverse reactionsName fallback
brand name: simvastatin
generic name: SIMVASTATIN
simvastatinSIMVASTATINNorthwind Health Company, LLCf32d512f-86fa-b70f-e053-2a95a90afd012026-01-01Warnings, Adverse reactionsName fallback
brand name: simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINNorthwind Health Company, LLCf7567996-4e81-7c12-e053-6394a90aa0872026-01-01Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINNorthwind Health Company, LLCf835af8f-7d84-1978-e053-6294a90a22ae2026-01-01Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
SimvastatinSIMVASTATINNorthwind Health Company, LLCf68e9cf8-a63f-1d64-e053-2a95a90a49232026-01-01Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINNorthwind Health Company, LLCf2f5ee7a-4f4e-12e9-e053-2a95a90a7eae2026-01-01Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINNorthwind Health Company, LLCf86de805-e4ec-4bca-e053-6294a90a1fc32026-01-01Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINProficient Rx LP8e686832-1caf-425c-9ca6-7eaade43b6fe2026-01-01Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINQPharma, Inc.f71f71db-e0dd-6609-e053-6294a90a44502025-12-19Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINA-S Medication Solutions09fa512b-f6c1-437d-be46-a8ddd36743b42025-12-19Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINA-S Medication Solutionsa53cfdd8-ca99-47a9-827d-1b06a03298782025-12-19Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINAphena Pharma Solutions - Tennessee, LLC450e722c-d55d-3e6d-e063-6394a90a52312025-12-03Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
simvastatinSIMVASTATINQPharma, Inc.c80b823c-b30f-0a9d-e053-2995a90a31e92025-12-03Warnings, Adverse reactionsName fallback
brand name: simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINA-S Medication Solutions468f87c8-75e3-444a-baeb-2d0f629802db2025-11-26Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINA-S Medication Solutions02245025-218d-4297-aeb6-91fefa1782912025-11-25Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINA-S Medication Solutions20fa794a-c30a-485e-9e69-3818ba085a0d2025-11-24Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINA-S Medication Solutions9986b59c-aeff-4ccd-8db3-7f1c4e6194202025-11-24Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINA-S Medication Solutions7cbf645d-b1d3-413d-a4c3-c1818ed6dfd12025-11-24Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINA-S Medication Solutions4312637b-1d6a-4d26-a1e8-caffcd7192df2025-11-24Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44310ORIG2011-05-26